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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010042
Receipt No. R000011755
Scientific Title Substantiative study of adherence enhancement manual categorized by residual factors
Date of disclosure of the study information 2013/02/15
Last modified on 2013/09/17

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Basic information
Public title Substantiative study of adherence enhancement manual categorized by residual factors
Acronym Substantiative study of manual categorized by residual factors
Scientific Title Substantiative study of adherence enhancement manual categorized by residual factors
Scientific Title:Acronym Substantiative study of manual categorized by residual factors
Region
Japan

Condition
Condition chronic disease
Classification by specialty
Medicine in general Obsterics and gynecology Dermatology
Oto-rhino-laryngology Orthopedics Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Aiming to improve the medication adherence of the patients with chronic diseases, prepare the "Manual for the care according to the unused medicines factors" for the community pharmacists, and clarify the clinical utility.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Community pharmacists: The rate to find unused medicines among the patients with chronic diseases.
The rate to solve problems.
(It records for one week at the time of baseline, one month after intervention, and three months after.)
Key secondary outcomes Community pharmacists:consciousness for the medication adherence.
Patients with chronic diseases:Unused medicine rate. Medication consciousness.
(A self-reported questionnaire is carried out for one week at the time of baseline and one month after intervention. )

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Community pharmacy is an allotment unit.Randomly allocate either the intervention group or the controlled group to each Community pharmacy.
All the pharmacists who may carry out the pharmaceutical care shall receive the training. After the training, the pharmacists shall confirm the unused medicines and solve the problem based on the Manual
Interventions/Control_2 Carry out the ordinary pharmaceutical care.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria [Pharmacy / Pharmacist]
1. To agree with the purpose of this empirical research, and to hope to participate in it
2. More than 30% of the visiting patients are with chronic diseases
3. To be able to have all the pharmacists that will carry out the medication guidance receive the training in one way or another
[Patients with chronic disease]
1.Aged 90 and below aged 30 and over
2.To be the patient with a chronic disease that has been receiving the continuous treatment
3. Even the patients that came for the first time, if he/she were receiving therapeutic medicine of the chronic disease, it can be a research object
Key exclusion criteria [Pharmacy / Pharmacist]
1. The pharmacies that have only one pharmacist on duty
[Patients with chronic disease]
1. The patient who cannot administer the medicine by him/herself
2. Patients with mental disorder
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiko Goto
Organization TOKYO UNIVERSITY OF SIENCE
Division name Faculty of Pharmaceutical sciences
Zip code
Address 2641,Yamazaki,Noda-Chiba,Japan
TEL 04-7121-4108
Email kgoto@rs.noda.tus.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiko Goto
Organization TOKYO UNIVERSITY OF SIENCE
Division name Faculty of Pharmaceutical sciences
Zip code
Address 2641,Yamazaki,Noda-Chiba,Japan
TEL 04-7121-4108
Homepage URL
Email kgoto@rs.noda.tus.ac.jp

Sponsor
Institute Laboratory of health psychology, Faculty of Pharmaceutical sciences, TOKYO UNIVERSITY OF SIENCE
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Faculty of Pharmacy, Meijyo University
School of education,Waseda University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 01 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 26 Day
Last follow-up date
2013 Year 07 Month 06 Day
Date of closure to data entry
2013 Year 07 Month 12 Day
Date trial data considered complete
2013 Year 07 Month 31 Day
Date analysis concluded
2013 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date
2013 Year 02 Month 14 Day
Last modified on
2013 Year 09 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011755

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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